Hazardous waste management system: standards applicable to generators of hazardous waste and standards applicable to owners and operators of hazardous waste treatment, storage, and disposal facilities--Environmental Protection Agency. Proposed rule

The Environmental Protection Agency (EPA) is today proposing amendments to its hazardous waste regulations under Subtitle C of the Resource Conservation and Recovery Act (RCRA). These amendments would replace the annual reporting requirements for hazardous waste generators and owners and operators of hazardous waste treatment, storage, ad disposal (TSD) facilities with a biennial survey of representative samples of those populations. This approach will provide verifiable data on a wider range of topics, better serve EPA's long term regulatory needs under RCRA, and reduce significantly the information burden on the regulated community.     

Hazardous waste management program: phase I interim authorization for Nebraska--Environmental Protection Agency, region VII. Phase I interim authorization

The State of Nebraska has applied for interim authorization of its hazardous waste program under Subtitle C of the Resource Conservation and Recovery Act and EPA guidelines for the approval of State hazardous waste programs [40 CFR Part 123]. EPA has determined that the State's program meets all applicable statutory and regulatory requirements and is granting Phase I interim authorization to Nebraska to operate in its jurisdiction a hazardous waste program in lieu of Phase I of the Federal hazardous waste program.     

State hazardous waste programs; procedures for revision of state RCRA programs--EPA. Proposed rule

EPA is today proposing to amend its requirements under 40 CFR 271.21(e) (formerly Section 123.13(e)) for the approval and revision of authorized state hazardous waste programs. One purpose is to ensure that states applying for final authorization under the Resource Conservation and Recovery Act of 1976, as amended, (RCRA) do not have to revise their programs and applications to respond to federal regulatory changes occurring while the states' applications are being prepared or processed. The second purpose is to provide all authorized states with one full year (or two years, if there is a need for state legislative action) from the effective date of amended federal regulations to make the revisions in their programs required by such federal amendments. This action would provide the state with an additional six months since the existing regulation requires that program revisions be made within one year (or two years) after the promulgation of amended federal regulations.     

Consolidated permit regulations and hazardous waste management system: Environmental Protection Agency. Notice of issuance of regulation interpretation memorandum

The Environmental Protection Agency (EPA) is issuing today a Regulation Interpretation Memorandum (RIM) which provides official interpretation of the issue of whether a generator who accumulates hazardous waste pursuant to 40 CFR 262.34, may qualify for interim status after November 19, 1980. This issue arose when the requirements for submitting a Part A permit application (one of the prerequisites to qualifying for interim status) were amended on November 19, 1980. The provisions interpreted today are part of the Consolidated Permit Regulations promulgated under Subtitle C of the Solid Waste Disposal Act, as amended by the Resource Conservation and Recovery Act, as amended (RCRA).     

Interim status standards for owners and operators of hazardous waste treatment, storage, and disposal facilities--Environmental Protection Agency. Interim final rule and interim final amendments to rules and request for comments

The Environmental Protection Agency [EPA] has issued standards applicable to owners and operators of hazardous waste management facilities as required by the Resource Conservation and Recovery Act [RCRA]. One of these standards bans the disposal of most containerized liquid hazardous waste in landfills, effective November 19, 1981. As a result of reconsideration of this restriction, EPA is today promulgating an interim final rule to allow the disposal of small containers of liquid and solid hazardous waste in landfills provided that the wastes are placed in overpacked drums [lab packs] in the manner specified in today's rule. The purpose of today's rule is to provide an environmental sound disposal option for generators of small containers of hazardous wastes, such as laboratories.     

The hazardous waste management system--Environmental Protection Agency. Interim final amendments to interim final and final rules

The Resource Conservation and Recovery Act (RCRA) requires that EPA set regulatory standards for all facilities which treat, store, or dispose of hazardous waste. In partial implementation of its requirement, on January 23, 1981, EPA set regulatory standards for incinerators that burn hazardous waste. These regulations were issued as "interim final," which means that, although they were issued in final form, the Agency invited public comment on them with a view to future amendment. Today, EPA is amending, on an interim final basis, certain of its regulations applicable to hazardous waste incineration facilities. Today's amendments include revisions to: the general standards for permitting hazardous waste incinerators (Part 264, Subpart O), published in the Federal Register on January 23, 1981; the interim status standards for hazardous waste incinerators (Part 265, Subpart O), revised on January 23, 1981; and the consolidated permit requirements for incinerators (Part 122), published on May 19, 1980 and January 23, 1981.U     

法治政府目标体系——中国法治政府建设十大成就之一

法治政府建设是中国特色社会主义法治国家建设的基础性环节。根据《法治政府建设实施纲要(2015—2020年)》的要求,到2020年基本建成以“职能科学、权责法定、执法严明、公开公正、廉洁高效、诚实守信”为目标体系的法治政府。经过多年的不懈努力,通过深化“放管服”改革和建立权力清单制度,有力地推动了政府职能科学、权责法定的组织性目标的实现;通过行政执法体制改革,构建行政执法三项制度,切实地完成了执法严明、公开公正的过程性目标;通过完善行政监督体系,深入政务诚信建设,有效推进了廉洁高效、诚实守信的伦理性目标的制度化。以此为标志,中国法治政府建设已经达成了预期目标。     

Hazardous waste management system; standards applicable to generators of hazardous waste; state program requirements. Environmental Protection Agency. Final rule

On February 26, 1980 and May 19, 1980, under the Resource Conservation and Recovery Act (RCRA), the Environmental Protection Agency (EPA) published regulations establishing a system to manage hazardous waste. Those regulations allowed hazardous waste generators to accumulate hazardous waste on-site without obtaining a permit or meeting financial responsibility requirements if they shipped the waste off-site within 90 days. On November 19, 1980, the Agency published an interim final rule which expanded the scope of the provision to include generators who treat, store or dispose of hazardous waste on-site. The final rule published today retains this change. As a result of public comments, the Agency is making several changes to the interim final rule. These changes (1) Clarify that the provision is applicable to all generators, including those who accumulate hazardous waste for the purpose of use, reuse, recycling and reclamation, (2) remove the requirement for use of DOT containers, (3) revise the labelling and marking requirements for wastes accumulated in containers and tanks; and (4) allow an extension to the 90-day accumulation limit in certain circumstances.     

Medicare program; changes to the hospital outpatient prospective payment system and calendar year 2003 payment rates; and changes to payment suspension for unfiled cost reports. Final rule with comment period

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In addition, it describes changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2003. This rule also allows the Secretary to suspend Medicare payments "in whole or in part" if a provider fails to file a timely and acceptable cost report. In addition, this rule responds to public comments received on the November 2, 2001 interim final rule with comment period (66 FR 55850) that set forth the criteria the Secretary will use to establish new categories of medical devices eligible for transitional pass-through payment under the Medicare's hospital outpatient prospective payment system. Finally, this rule responds to public comments received on the August 9, 2002 proposed rule for revisions to the hospital outpatient prospective payment system and payment rates (67 FR 52092). CMS finds good cause to waive proposed rulemaking for the assignment of new codes to Ambulatory Payment Classifications and for the payment of influenza and pneumococcal vaccines under reasonable cost; justification for the waiver will follow in a subsequent Federal Register notice.     

Notification procedures for states implementing "alternative mechanisms" in the individual health insurance market--HCFA. Notice

This notice generally describes the statutory provisions under section 111 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) that guarantee availability of individual health insurance coverage to certain individuals with prior group coverage. It also provides procedural guidance for States that intend to implement an alternative mechanism under section 111 of HIPAA. Finally, this notice describes the statutory provisions that will apply in a State that does not implement an acceptable alternative mechanism. This notice does not establish new policy or requirements.     

Hazardous waste management system; identification and listing of hazardous waste--EPA. Final rule and response to comments

On May 19, 1980, as part of its regulations implementing section 3001 of the Resource Conservation and Recovery Act (RCRA). EPA promulgated a series of criteria for listing wastes as hazardous. On July 19, 1991, the Agency proposed to conform the language of the regulation to reflect the Agency's intent and consistent interpretation of that regulation. Today's rule finalizes the proposed rule.     

Medicare program, changes to the hospital outpatient prospective payment system and calendar year 2004 payment rates. Final rule with comment period

This final rule with comment period revises the Medicare hospital outpatient prospective payment system to implement applicable statutory requirements and changes arising from our continuing experience with this system. In addition, it describes changes to the amounts and factors used to determine the payment rates for Medicare hospital outpatient services paid under the prospective payment system. These changes are applicable to services furnished on or after January 1, 2004. Finally, this rule responds to public comments received on the August 12, 2003 proposed rule for revisions to the hospital outpatient prospective payment system and payment rates (68 FR 47966).     

NATIONAL VICTIM COMPENSATION: Its Cost and Coverage

In recent years, numerous states have established programs to compensate victims of violent crime, and efforts to enact a national victim compensation law continue. One of the major obstacles to positive legislative action on victim compensation programs has been the lack of reliable estimates of the potential costs of such programs. In this article, a series of compensation program models with varying eligibility criteria are examined. Data from a variety of sources—victimization surveys, the Uniform Crime Reports, and existing state compensation programs—are brought together to determine the effects of differing statutory criteria on the coverage and costs of possible national victim compensations programs. Program model recommendations are made and policy issues are discussed.     

Exemption of certain research and demonstration projects from regulations for protection of human research subjects--Office of the Secretary, HHS. Final rule

The Department of Health and Human Services (the Department or HHS) is including among the types of research specifically exempt from the application of the regulatory requirements of 45 CFR Part 46 (protection of human research subjects) research and demonstration projects conducted under the Social Security Act and other federal statutory authority and designed to study certain public benefit or service programs, the procedures for obtaining benefits or services under those programs, and possible changes or alternatives to those programs or procedures, including changes in methods or levels of payment. These demonstration and service projects are already subject to procedures which provide for extensive review by high level officials in various program administration offices. Review by an Institutional Review Board (IRB), as required under Part 46, would be duplicative and burdensome to state and local agencies and to other entities participating in demonstration projects. Removal of this unnecessary layer of review will not only reduce the cost of the projects but help to avoid unnecessary delays in project implementation. However, in order to ensure the continued protection of human subjects participating in such research activity, the Department is adding a specific requirement of written, informed consent in any instance, not reviewed by an IRB, in which the Secretary determines that the research activity presents a danger to the physical, mental or emotional well-being of a participant.     

Current good manufacturing practice and investigational new drugs intended for use in clinical trials. Final rule

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND). In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: CGMP for Phase 1 Investigational Drugs" dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs. FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality. This action will also streamline and promote the drug development process.     

金融危机下企业经济性裁员的法律思考

在金融危机影响下,企业常常以经济性裁员来减少企业的人力成本支出,这是企业经营自主权的体现。但这种经济性裁员涉及人数多,稍有不慎就会产生严重的法律后果和社会影响。所以,在劳动合同法规范下,经济性裁员必须符合法定条件,履行法定程序。本文从法律适用的角度出发,在论述金融危机下企业经济性裁员的法律后果与影响的基础上,对我国现行经济性裁员的法律规定及存在的问题进行了具体分析,并对金融危机下完善我国企业经济性裁员制度提出了若干建议。     

Exemption of certain research and demonstration projects from regulations for protection of human research subjects--DHHS. Notice of proposed rulemaking

The Department of Health and Human Services (the Department or HHS) is proposing to include among the types of research specifically exempt from the application of the regulatory requirements of 45 CFR Part 46 (protection of human research subjects), research and demonstration projects conducted under the Social Security Act and other Federal statutory authority and designed to study certain public benefit or service programs, the procedures for obtaining benefits or services under those programs, and possible changes or alternatives to those programs or procedures, including changes in methods or levels of payment. This proposed amendment to the revised final regulations for protection of human research subjects (published January 26, 1981) would, in effect, restore to the regulations an exemption included in the initial notice of proposed rulemaking (NPRM) (published August 14, 1979). These demonstration and service projects are already subject to procedures which provide for extensive review by high level officials in various program administration offices. Review by an IRB would be duplicative and burdensome to state and local agencies and to other entities participating in demonstration projects. Removal of an unnecessary layer of review will not only reduce the cost of the projects but help to avoid unnecessary delays in project implementation.